Clinical Trials Part 1: Navigating the Clinical Trial Process
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- Опубліковано 8 вер 2024
- In this video, we begin to explore why a clinical trial may be required and how to navigate through the clinical trial process. This video focuses on FDA regulations. Future videos delve into the clinical trial process as regulated by Health Canada, the Medicines and Healthcare products Regulatory Agency, and the relevant regulations in EU and EEA countries. This video sets the stage for our next segment on the products liability implications of clinical trials.
Music I Use: Bensound.com/free-music-for-videos
License code: X687OFDALNRMBXMN
Contents of this Video
00:00 - Intro
01:05 - Why do Clinical Trials Matter?
02:03 - When are Clinical Trials Required?
02:38 - What regulatory body oversees your clinical trial?
03:21 - The Phases of a Clinical Trial.
04:29 - Phase 1
05:09 - Phase 2
05:31 - Phase 3
05:43 - Phase 4
06:09 - Devices - Clinical Trial for Class I, II and III Devices
07:25 - Request for approval from the FDA
07:57 - Conclusion next in series - Products Liability Implications
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